The Long-term Impact of Massage Chairs on Sleep Quality.

NCT06788288 | Recruiting

• 1 other identifier: 2334-5/4-2/7.2.2024
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Modern technology is reshaping the massage industry, improving relaxation and well-being with pioneering devices. The automatic massage chairs stand as a testament to this evolution, integrating ergonomic design with advanced massage techniques to facilitate deep tissue relaxation, and sleep quality and enhance overall well-being. Aim: The aim of the current study is to assess the long-term impact of the new generations of massage chairs prior to bed-time in aspects related to sleep and quality of life in individuals with severe symptoms of insomnia.

Conditions

Insomnia

Keywords

poor sleepers; stress; fatigue

Outcome Measures

Primary Outcomes (2)

• Sleep Efficiency

  Total sleep time over Time spend in bed

  At baseline, after each month and at the end of the 3 months period.

• Insomnia Score

  For the calculation of the Insomnia score, the Athens Insomnia Scale (AIS-8) will be used. The score ranges from 0 - 24 with a higher number implying worse insomnia symptoms.

  At baseline, after each month and at the end of the 3 months period.

Secondary Outcomes (1)

• Sleep Quality Score

  At baseline, after each month and at the end of the 3 months period.

Study Arms (2)

Group 1 - On-Off-On

EXPERIMENTAL

Participants will follow a crossover design with a one-month interval period for three months in total. Participants will be randomly assigned into two equal-sized groups receiving the intervention (massage) following a distinct pattern: for the Group-1: one month on, one month off, one month on. During the "on" period, the massage chair will be located at the participant's house while during the "off" period, the massage chair will be removed from the participant's house (washout period).

Other: Massage Chair session; Other: Washout period

Group 2 - Off-On-Off

EXPERIMENTAL

Participants will follow a crossover design with a one-month interval period for three months in total. Participants will be randomly assigned into two equal-sized groups receiving the intervention (massage) following a distinct pattern: for the Group-2: one month off, one month on, one month off. During the "on" period, the massage chair will be located at the participant's house while during the "off" period, the massage chair will be removed from the participant's house (washout period).

Other: Massage Chair session; Other: Washout period

Interventions

Massage Chair session OTHER

The intervention is composed of a full-body relaxation massage offered by an automatic electric massage chair. The intervention will last for 3 months while the participant will change between massage and washout periods.

Also known as: Automatic Electric Massage chair

Group 1 - On-Off-On; Group 2 - Off-On-Off

Washout period OTHER

During this phase, participants will spend on month without any intervention (massage) accounting for a washout period.

Also known as: no intervention

Group 1 - On-Off-On; Group 2 - Off-On-Off

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Sex at birth
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• score of ≥16 on the Athens Insomnia Scale (AIS-8)

You may not qualify if:

• history of mental illness,
• history of epilepsy
• acute or chronic condition that would limit the ability of the patient to participate in the study

Sponsors & Collaborators

• University of Thessaly: lead
• University of Nicosia: collaborator

Study Sites (1)

School of Physical Education, Sports and Dietetics, TEFAA

Trikala, Thessaly, GR42100, Greece

RECRUITING

Related Publications (3)

• Xie J, Fu M, Liu T, Li S, Liu G, Wang J, Ji C, Zhang T. Clinical studies on the electric automatic massage therapy for recovery of acute sports fatigue. Technol Health Care. 2023;31(S1):185-197. doi: 10.3233/THC-236016.

  PMID: 37038791 BACKGROUND

• Kim JW, Lim AR, Lee JY, Lee JY, Lee S, Choi YJ, Kim YH, Park KH. The clinical effect of an electric massage chair on chemotherapy-induced nausea and vomiting in cancer patients: randomized phase II cross-over trial. BMC Complement Med Ther. 2024 Apr 19;24(1):163. doi: 10.1186/s12906-024-04464-8.

  PMID: 38641782 BACKGROUND

• Khairudin MN, Vallikkannu N, Gan F, Hamdan M, Tan PC. Electric massage chairs reduce labor pain in nulliparous patients: a randomized crossover trial. Am J Obstet Gynecol MFM. 2024 Apr;6(4):101324. doi: 10.1016/j.ajogmf.2024.101324. Epub 2024 Mar 4.

  PMID: 38447674 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Fatigue

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Giorgos Sakkas, PhD

  University of Thessaly

  STUDY CHAIR

Central Study Contacts

Giorgos Sakkas, PhD

CONTACT

+30-24310 47022; gsakkas@uth.gr

Ilias Ntoumas, MSc

CONTACT

+30-24310-47020; intoumas@uth.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 23, 2025
• Study Start: March 4, 2024
• Primary Completion: December 15, 2025
• Study Completion: December 31, 2025
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: January 2026 - January 2027
• Access Criteria: Written request

Locations

GR (1)